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Biopharmaceutical Process & Facility Validation

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The validation is the one of key factors of the biopharmaceutical industry. From the research to
commercial lunching of the biopharmaceutical product, the validation of the process, analytical
method, and product itself is the one of key factors and basic requirement to prove the safety
and efficacy of the target product.
Recently, the overall validation regarding current Good Manufacturing Process (cGMP) has been
become common requirement and also required by the laws.
Topics will be covered including personnel qualification, equipment qualification, process
validation, cleaning validation, computerized system validation, and also method validation.

저자정보

  • Hyuk Jae LEE Regulatory Affairs Team, Quality & Regulatory Compliance Department, Celltrion,Inc

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